Robyn Meurant
Robyn Meurant is a medical scientist by training and has run large serology laboratories in Australia before she joined the Therapeutics Goods Administration as the regulator of IVDs for Australia. Since then, she has moved to Europe, and worked at WHO in the Prequalification of IVDs programme. Until recently she was the head IVD regulatory consultant for NSF until setting up her own company, ACT-IVD in August 2021. Here, she uses her regulatory, technical and international knowledge of IVDs to assist manufacturers, NGOs and governments. She currently serves as a member of the MHRA Expert Advisory Group for IVDs and is a researcher for Cambridge University for a UKRI-funded project on international Covid-19 testing policies.
Regulation of Diagnostics 101 Part 1 – An Introduction
The purpose of this series is to introduce the reader to how diagnostic tests, known more accurately as in vitro diagnostic medical devices or IVDs, are regulated internationally. This first issue takes a bird’s eye view of international regulation of IVDs, and we will look at some critical definitions – always important when there is…